The invention relates generally to assessing the hemocompatibility of a material. More specifically, the invention relates to an assay for detecting conformational changes in adsorbed fibrinogen as a measurement of material hemocompatibility.
In the field of medical devices, many devices are designed to come into direct contact with patient blood. Such devices may include in-dwelling devices such as catheters and stents, as well as extra-corporeal devices such as oxygenators and apheresis units. Devices in contact with human blood may trigger certain biological responses, such as inflammation or coagulation of the blood. Such coagulation of the blood may be mediated by certain blood proteins, such as fibrinogen.
Modifications in the conformation of adsorbed fibrinogen may lead to the exposure of certain internal epitopes. Exposure of such epitopes may result in platelet adhesion or thrombosis. Therefore, a sensitive and robust test for detecting conformation changes of fibrinogen adsorbed on material surfaces may be beneficial for the screening and development of novel biomaterials.
The currently available analytical technologies for assessing the conformation of adsorbed fibrinogen are complicated, expensive, time-intensive, and of limited sensitivity. As such, these techniques are unsuitable for high-throughput biomaterial screening.